Misoprostol: Have you heard about this small, inexpensive, and most importantly available pill that can save women’s lives? Pragmatic Brazilian women first discovered the potential of misoprostol (or Cytoteca, in their parlance) in the 1980s. According to the label on this widely used peptic ulcer drug, it was not to be taken during pregnancy as it could induce bleeding. Living in a country with very restrictive policies and little access to safe abortion services, they recognized the opportunity to circumvent the system and, by word of mouth, spread the word to other women about this easily obtainable pill that could help them safely end an unwanted pregnancy.

Thirty years later, women in countries around the world are beginning to do the same-continuing to spread the word, talking to each other about misoprostol, and trying to get their hands on these pills. The women who are accessing the drug in their communities and taking it by themselves have shown us that there are relatively few health risks involved with misoprostol. What began in Brazil as a natural public health experiment has been validated by rigorous clinical studies conducted by international groups such as the World Health Organization and Gynuity. These studies have shown that the use of misoprostol for abortion is very safe, especially when taken early on in the pregnancy; while not as effective as when taken in combination with mifepristone (another abortion pill), misoprostol taken alone will safely terminate 75 to 90 percent of early pregnancies when taken as directed.

Misoprostol has also been proven to have numerous other lifesaving properties, including the ability to prevent and treat postpartum hemorrhage and to induce labor. It is registered in more than 85 countries, usually as an anti-ulcer medication, and is used off-label by clinicians around the world for numerous reproductive health indications. In addition to these clinical uses, we are beginning to see positive public health outcomes from community-based use of misoprostol. In countries where abortion is restricted and women are using misoprostol, we have seen a reduction in infections. And in under-served communities, where women delivering at home are taught to take misoprostol immediately after delivery, postpartum hemorrhage is significantly reduced.

If we have a cheap and readily available drug that can prevent and treat the two largest causes of maternal mortality worldwide-postpartum hemorrhage and unsafe abortion-why have we not taken more advantage of this exciting technology? Given the global attention being paid to meeting the fifth Millennium Development Goal (MDG 5)-that of reducing maternal mortality-it is difficult to fathom why we continue to squander the opportunity misoprostol offers us.

The public introduction of any new technology takes time and is not easy; the introduction of emergency contraception is just one of the latest examples. Reproductive health advocates have been working for decades to increase women’s access to this safe, effective, and non-abortifacient technology. While much progress has been made around the world, the recent action of the Obama administration to prevent full over-the-counter access in the United States is a sad illustration of the hurdles women face in accessing reproductive health technologies. The hurdles we face in introducing misoprostol will be even higher given three inherent characteristics:

It has multiple indications, including abortion.

It is only “second best” to existing drugs, competing with a “gold standard.”

It can be used by women without the assistance of a provider.

The Challenge of Multiple Indications

Misoprostol’s greatest clinical asset-the fact that it can be used for numerous reproductive health indications-also poses enormous challenges for implementation. As mentioned, misoprostol has many uses: to both prevent and treat postpartum hemorrhage, to induce labor, to induce abortion, and for post-abortion care. But these multiple indications pose two major challenges for implementation, one political and the other educational.

The political challenge lies in overcoming the stigma of abortion. A survey we conducted in 2010 of organizations that were working with misoprostol for postpartum hemorrhage revealed that the second biggest barrier to the introduction of misoprostol was its association with abortion. To quote one respondent who was asked about the challenges and opportunities for its introduction: “Hypersensitivity of misoprostol as an abortifacient [is a barrier]. We see this in clinical providers, government officials, even donors-a disproportionate concern that if misoprostol were to be made available for PPH prevention and treatment, it would be used for abortion. This is a major obstacle in accepting misoprostol for other OB/GYN indications-the abortion stigma.”

This political fear is strong, despite the evidence that all indications of misoprostol use are potentially life-saving. And because of this fear, there is a great deal of sidestepping going on as organizations begin to introduce misoprostol at the community level for postpartum hemorrhage while trying to stay clear of its potential use for abortion. “We feel there is tremendous promise for use of misoprostol for [postpartum hemorrhage], so we do not want to jeopardize that application by highlighting the other indications,” said another respondent.

The political controversy only exacerbates the programmatic challenge of informing women, their partners, and their health-care providers of the different doses and the proper timing of administration needed for different indications. This is usually facilitated by the registration and labeling of products in appropriate doses for each of misoprostol’s various indications.

But because the vast majority of misoprostol use is currently done “off-label”(it’s being used for an indication other than the one the product is registered for) there is an urgent need to find ways to get women accurate information about how to use it for the different reproductive health purposes. Mobile technologies are beginning to open the information door to some women, but challenges remain. We need to find ways of achieving a broader level of knowledge about correct use, and to help women differentiate between the proper uses for each indication, including abortion.

The Challenge of Competing Against a “Gold Standard”

For both indications-abortion and postpartum hemorrhage-misoprostol is the second best option, up against another drug long considered the “gold standard.” For abortion, the most effective medical abortion regimen is mifepristone combined with misoprostol; when used together, the success rate is 93 percent, and when misoprostol is used alone it is 78 percent successful. Thus, where mifepristone is available, such as in the United States, it is the drug of choice.

In the case of postpartum hemorrhage, injecting oxytocin is the first line of treatment because, when oxytocin is at full potency, it is more effective than misoprostol. But oxytocin, unlike misoprostol, needs to be refrigerated. As a result, the quality of the drug is easily compromised by exposure to heat-a problem in many Global South countries. Finally, the administration of oxytocin requires that the women deliver in a health-care facility, another “gold standard” established by the medical community.

In reality, in many places in the world, we are not meeting these “gold standards,” in spite of decades of trying to do so. Mifepristone is far from universally available, oxytocin stock-outs are common in many places and/or the quality has been compromised, and many women continue to deliver at home, without skilled attendants. In these situations, misoprostol is a very good alternative and even has the advantage of being in pill form, making home use possible and safe.

Which brings us to the third challenging characteristic…

Women Can Use it Without the Assistance of a Provider

Another survey respondent summed it up nicely: “This is a gender issue. Misoprostol faces this unbelievable barrier because it is a drug for women.”

Therein lies both the greatest opportunity and the greatest challenge.

Misoprostol has the potential to be a game-changer when it comes to maternal health precisely because it can be used safely and effectively by women themselves. The foremost obstacle to achieving MDG 5 is the weak health-care infrastructures of many countries. Misoprostol offers the opportunity to circumvent this obstacle for two of the three principal causes of maternal mortality-postpartum hemorrhage and unsafe abortion. Yet despite growing evidence that women can safely and effectively take misoprostol by themselves, in their homes, for both uses, health-care practitioners are insisting on controlling access to the drug, viewing it as an important addition to their clinical tool kit and a service only they can “provide” instead of as a pill that can be used by women, to help themselves, with little or no assistance from a health-care provider. The failure to relinquish control over the use of misoprostol not only gets in the way of women who are intent on helping themselves, it risks negating the most attractive aspect of this new technology: it’s self-use properties. To quote another respondent to our survey: “Many people are more concerned about what might happen with an intervention (i.e., side effects) than what might happen without an intervention (i.e., maternal death). In this case, women are more likely to be harmed by omission of the intervention than from any danger posed by the intervention itself.”

Obviously, as we work to make misoprostol available at the community level we need to acknowledge that it is a powerful drug and that incorrect use can lead to serious consequences-such as uterine rupture during labor induction. While some would use this as an argument for placing restrictions on access, we see this as a call to put accurate and comprehensive information about its safe use into the hands of women.

The Way Forward

This week policy makers from around the world are gathering in Malaysia at the third Women Deliver Conference to continue to share ways of reducing maternal mortality. Misoprostol is the single-best opportunity to do just that. But the true potential of this simple and cost-effective technology lies in our willingness to abandon our “provider” frame and put the pills directly in women’s hands. Our challenge is to let women be the shapers and the users of this new technology, not the beneficiaries of what we can provide or what we think they need. Can we stop worrying about women’s “misuse” or “abuse” of misoprostol and show that we truly trust women with their own reproductive health care? Let us remember that it was women who discovered this drug in the first place, specifically to circumvent the weakness of the health-care system. Let us give them back this powerful tool and get out of their way. Our responsibility is to ensure that women have easy access to the pills and all the knowledge necessary to use them effectively and safely.

Great article in the Argentine newspaper Pagina 12, about a network of women, called Pink Rescue, who accompany other women in the use of misoprostol for safe abortion. They give information, advise about risks and help make sure the women get a checkup afterward.

An activist dressed as a nun holds a placard that reads “they decided on your body” above pictures of the parliamentarians who are against abortion, during a rally outside a church in support of legalisation of abortion in Valparaiso city, about 121 km (75 miles) northwest of Santiago, September 28, 2012. REUTERS/Eliseo Fernandez

By Anastasia Moloney

BOGOTA (TrustLaw) – When Carolina answers an evening call in the Chilean capital of Santiago, she is acutely aware that she could be giving potentially life-saving information to a woman on the other end of the line.

Carolina is one of 30 self-described “militant feminist” volunteers who run an abortion hotline in Chile, providing information to women about how they can induce an abortion using the drug misoprostol.

The World Health Organisation recommends misoprostol, both taken on its own and combined with another drug mifepristone, as a safe and effective way for women to have an abortion in the first trimester of pregnancy.

In a country where abortion is a crime under any circumstances – even in cases of rape, incest or if the life of the mother or foetus is in danger – the hotline has become a lifeline, offering women a way to sidestep Chile’s blanket ban.

“Regardless of any laws, if a woman feels she needs an abortion she will get one. We know women in Chile have abortions every day. Abortion is a reality,” said Carolina, a volunteer at Lesbians and Feminists for the Right to Information, the Chilean group that runs the hotline.

“What we aim to do is to help women avoid having unsafe and clandestine abortions. The phone line is our strategy to fight that,” Carolina told TrustLaw in a phone interview in Santiago.

Originally invented as an ulcer drug, misoprostol induces an abortion by causing contractions of the uterus and is from 75 to 90 percent effective when taken correctly, WHO says.

Neither misoprostol nor mifepristone is risk-free and incomplete abortions can happen. But doctors say inducing an abortion with oral drugs rather than a surgical operation means it is less likely for an infection or a uterus perforation to occur.

UNSAFE ABORTIONS

In much of Latin America, Asia and Africa, restrictive laws or blanket bans on abortion force millions of women with unwanted pregnancies to have illegal and often unsafe abortions every year, according to WHO.

Some 47,000 women die from botched abortions each year around the world, says WHO. In Latin America meanwhile, deaths from botched abortions, often caused by severe bleeding, infections or a combination of both, account for 17 percent of maternal deaths in the region, the United Nations agency says.

That is why volunteers like Carolina are adamant it is vital to give women the information they need to stop preventable deaths from unsafe abortions.

“All women have the right to know about how to get a safe abortion,” Caroline, 32, said.

Since the hotline started in 2009, it has received more than 12,000 calls, up to 15 a day.

Sometimes it is a single mother of three who says she cannot afford to have another child. Other times, it is a young woman who does not feel ready to be a mother.

“We receive calls from young, old, poor, rich, married, single women, those with children and those without. Abortion is something that affects all kinds of women in Chile,” said Carolina, a sociologist.

Chile, like much of Latin America, is predominantly Catholic and the Catholic Church and conservative lawmakers argue that abortion infringes on the right of an unborn child, which should be protected by law at all costs.

Abortion, therefore, is both a taboo issue in Chile and a crime that can lead to imprisonment for those who perform abortions or assist on them. Because of this, hotline volunteers prefer to keep a low profile. They wear masks when promoting the hotline at public meetings and most choose not to give their full names.

It also means volunteers like Carolina are careful to only share public information with callers over the age of 18 based on a script approved by a lawyer.

“We don’t convince women to have an abortion. All women who call have already made up their minds to have an abortion,” said Carolina.

“We just provide women with information about how to have a safe abortion using misoprostol, correctly following WHO protocols.”

BLACK MARKET PILLS

On top of the country’s absolute ban on abortion, women in Chile face the additional challenge of getting hold of misoprostol.

The drug was pulled off pharmacy shelves in Chile, where it had been available with a prescription, under Michelle Bachelet, the former first female president of Chile, who now heads the U.N. Women’s agency.

It means women have to try their luck on the black market. It costs around $250 for the 12 pills needed for an abortion.

Chile’s safe abortion hotline was the brainchild of Dutch doctor and former Greenpeace activist, Rebecca Gomperts. Through her pro-choice group, Women on Waves, Gomperts has helped launch the abortion hotline in Chile, along with hotlines in Argentina, Ecuador, Peru and Venezuela.

“Medical abortion is such a revolution. Women … can take their health, and life, in their own hands,” Gomperts told TrustLaw in an interview last year.

“PUSH AND PULL”

In Chile, any moves to decriminalise the country’s abortion laws are still a long way off, Carolina says.

“Chile is a very, very conservative country in all senses. The opinion of the Catholic Church holds a lot of weight in Chile. Maternity is seen as something sacred,” Carolina said.

“Currently, it’s not a priority among Chilean lawmakers to change the abortion laws and push for reform. Abortion isn’t an important issue in public debate.”

While there’s little headway on reproductive rights in Chile, elsewhere in Latin America attitudes have been changing.

In Colombia, for example, an absolute ban on abortion was partially lifted in 2006. A year later, abortion was made legal in Mexico City during the first 12 weeks of pregnancy and more recently last year in Uruguay.

“There’s a push and pull going on in Latin America,” Marianne Mollmann, a senior policy advisor on sexual and reproductive rights at Amnesty International, told TrustLaw. “The countries that are stuck are Central America and Peru.”

As for Chile, the country remains a bastion for strict anti-abortion laws that force women to rely on underground activists and their telephone hotline to get a safe abortion.

Volunteers for the Safe Abortion Hot Line in Chile routinely wear masks when showing support in public for the organization in a country where abortion is illegal under any circumstances.

SANTIAGO, Chile – Every time the phone rings, Angela Erpel feels her nerves swell. Sometimes it is a scared teenager on the other end, or a desperate mother of three. There are the angry ones, too, with callers playing the sounds of crying babies or sending text messages with pictures of aborted fetuses.

Then Ms. Erpel, 38, a sociologist who volunteers at Chile’s Safe Abortion Hot Line, gathers herself and settles into a familiar dialogue on the use of misoprostol, a drug that will induce a medical abortion.

“We don’t give them a moral guide or advice; we only provide information,” she said.

Since the hot line began in 2009, volunteers spread across this long, thin country have taken turns answering tense calls from women seeking information about abortion every evening from 7 p.m. to 11 p.m. There have been more than 12,000 calls so far, and they continue rolling in at a steady clip.

In a country where abortion is entirely illegal, even in cases of rape or when a woman’s life is in danger, the hot line is a risky endeavor. Operating in a legal gray area, volunteers face a daunting prison sentence if a conversation veers too far from a lawyer-approved script. The hot line already has had three lawsuits brought against it, though all were eventually dropped.

According to the law, having an abortion carries a penalty of 5 to 10 years in prison, depending on the circumstances, while doctors and others who perform an abortion or assist with one could face up to 15 years, prosecutors say. In practice, however, fewer than 500 cases have been prosecuted over the last several years.

“I think there is a certain sensitivity to the social conditions behind these abortions, such as poverty or rape or teenage pregnancy,” explained Paula Vial, a lawyer and former public defender in Santiago.

Beyond the legal consequences, the 30 hot line volunteers are keenly aware of the social ramifications of taking an active role in such a polarizing issue. They wear masks when promoting the hot line at public gatherings, and are often vague about the details of their volunteer work in their daily lives. Many fear losing their jobs or driving a wedge into personal and family relationships. Indeed, Ms. Erpel was the only volunteer willing to go on the record about her work with the hot line, and even she is usually circumspect about it.

“It’s complicated,” she explained. “I’m open about being in an organization, but not necessarily that I work directly with abortion.”

Abortion was not always a clandestine affair in Chile. The current law that strictly bans it was one of the final acts of the dictatorship. In 1989, shortly before relinquishing power, Gen. Augusto Pinochet ended a tradition of legal abortion dating to 1931, in which a pregnancy that threatened a woman’s life, or a fetus that was not viable outside the womb, could be terminated. Chile’s law now is one of the strictest in the world.

By contrast, Uruguay legalized abortions in the first trimester for any reason last October, joining Guyana and Cuba as Latin American countries with broadly legalized procedures. Abortion is also legal in Mexico City. But Chile has remained a socially conservative country, after 20 years of economic growth and the election in 2006 of a woman as president.

“The hierarchy of the Catholic Church has had a very strong influence in public policy,” said Claudia Dides, a spokeswoman for the Movement for the Legal Interruption of Pregnancy.

In a pivotal case in 2008, Karen Espíndola, then 22, learned in her 12th week of pregnancy that her fetus had holoprosencephaly. Fetuses with the condition have a single-lobed brain, and most die before they are born. It is a common reason for terminating a pregnancy.

Ms. Espíndola sought an abortion, appealing to the president and setting off a national conversation over abortion. In February 2009, Ms. Espíndola gave birth to Osvaldo, who died in 2011.

“In reality he was never conscious he was alive,” she lamented. “He fought to breathe; he was fed through a tube. We all suffered a lot. Nobody here is a winner.”

Chile has witnessed a swell of liberal social movements in recent years, with gay men and lesbians pressing for the country’s first hate-crime legislation, environmentalists stalling dam-building projects in Patagonia, and students pushing for an overhaul of the education system.

Advocates contend that abortion rights sentiment bubbles near the surface as well, but the government has pushed back.

After criticizing the abortion hot line in the news media, the Ministry of Women started a hot line of its own. It is attended by psychologists and social workers who answer calls from men or women looking for information or support when facing what the ministry calls an “abortion situation” or “post-abortion syndrome.”

“Maternity, one of the most satisfactory experiences in the life of a woman, can go through difficult and desperate moments,” Minister Carolina Schmidt said at the time the government hot line began.

“If you help that person define what is troubling them and making them think of an abortion, and together you find a solution, in the end the person decides for life and her child,” said Victoria Reyes, director of assistance for Foundation Chile United. “We are convinced the second victim of abortion is the woman; the woman who has an abortion carries that guilt.”

The government reported several hundred adoptions in 2011, but it estimates 120,000 abortions, in a country with a population of about six million women from 15 to 64 years old.

Misoprostol, sold under the brand name Misotrol in Chile, has changed the way many of those abortions are performed. The drug was originally developed as an ulcer medication, and its warning label advised that, in excess, misoprostol would cause a woman to miscarry. Before long, women in countries with little or no access to safe abortions were using the drug to do that very thing.

Misoprostol “is a revolution for women,” said Rebecca Gomperts, founder of the Dutch organization Women on Waves. “Even where abortion is illegal and women don’t have a doctor, or they are poor, they still have a way to do a safe abortion.”

The abortion hot line is Ms. Gomperts’s creation. A medical doctor and former Greenpeace activist, she realized in 1999 that it was possible for a ship sailing under a Dutch flag to take women from countries where abortion is illegal to international waters to administer misoprostol.

Before departing Chile, Women on Waves helped set up the abortion hot line, training volunteers how to discuss misoprostol according to World Health Organization guidelines.

There are now five abortion hot lines in South America: in Argentina, Chile, Ecuador, Peru and Venezuela.

Misoprostol was taken off pharmacy shelves in Chile under Michelle Bachelet, the former president who now runs the United Nations’ agency for women’s advancement, so access to the drug is almost entirely a black market transaction.

One 29-year-old lawyer who became pregnant a few months ago said she paid $300 for the necessary 12 pills.

“To meet someone in a clandestine place, hoping they aren’t a police officer, wondering if they are even giving you the right pills, knowing that you could go to prison when all you want to do is exercise your right as a woman is horrifying,” the lawyer said on the condition of anonymity to avoid prosecution.

To its volunteers, the Safe Abortion Hot Line stands as a simple equation – 30 women and a single cellphone that gets passed among them. This month, they expanded: they released an abortion manual on using misoprostol.

Occasionally, women call back the hot line after a successful abortion, but more often the volunteers never know the outcome.

“To avoid judgement and fear, it is always useful step into the shoes of another person. I invite you into mine.”

So begins the journey of a 19-year-old Mexican named Claudia, protagonist of an inventive computer game.

¿No Te Baja? which translates as Missed Your Period? makes use of bright colors, engaging cartoon characters and relatable, non-technical, language to inform and guide users through the steps they can take to terminate a pregnancy using Misoprostol. The website takes the form of an interactive, Choose Your Own Adventure style game, where users click through to different scenarios that change according to their own personal situation and decisions.

Misoprostol, a drug used to treat ulcers, is easily available for purchase throughout Mexico, and, unlike in the United States, does not require a prescription. Use of Misoprostol to terminate pregnancy is widespread in parts of Mexico where abortion is illegal, but pharmacy workers often lack the knowledge of how the drug should correctly be administered — and criminalization means that helpful information is scarce.

Although abortion of up to 12 weeks of pregnancy is available on demand in Mexico City, the situation is quite different in the rest of the country. In fact, Mexico City’s 2007 legalization of abortion prompted a backlash from 17 other states, which passed amendments stating that life begins at conception, ushering in a much stricter enforcement of already existing anti-abortion laws.

Users of No Te Baja, through the actions of Claudia and her boyfriend, go through each detailed step of the process of self-administering a medication abortion: from the initial pregnancy test to the decision whether or not to involve the partner; the signs and symptoms of an ectopic pregnancy to calculating gestational age to indicate whether or not use of Misoprostol will be effective-and if it will be safe to self-administer.

The game advises that Misoprostol can be purchased in most pharmacies and that it may be sold under various other commercial names including Cytotec, Cyrox, and Tomispral. Users receive detailed information on how to administer Misoprostol through the mouth or the vagina, noting that, in the event of having to seek medical attention, medical personnel would likely be able to detect the remnants of the pills inside the vagina- important information for women living in areas where they can be prosecuted for inducing an abortion.

The central Mexican state of Guanajuato, where hospital staff report suspicious miscarriages to the police, is one such place. The Nation described the state’s approach to dealing illegal abortion in a January 2012 article by Mary Cuddehe:

“The state has opened at least 130 investigations into illegal abortions over the past decade, according to research by women’s rights groups, and fourteen people, including three men, have been criminally convicted. Given Mexico’s 2 percent national conviction rate during its most violent period since the revolution, that’s a successful ratio.”

No Te Baja doesn’t end with the final dosage of medication: users (and Claudia) are informed of what signs to look out for that would require medical attention, and of how to tell if the abortion is incomplete. The final stages of the game offer information on how to avoid another unplanned pregnancy with detailed descriptions of different methods of contraception.

18.09.12

A woman has been jailed for eight years at Leeds Crown Court for obtaining an abortion at 39 weeks of pregnancy in 2009.

Sarah Catt, of Sherburn-in-Elmet, North Yorkshire is believed to have become pregnant following an affair with a colleague. She discovered she was 30 weeks pregnant following a scan at a Leeds hospital and later claimed to have had a legitimate abortion at a local clinic.

Investigation of her computer revealed however that she had purchased medication used to induce labour on the internet.

Catt, who is married with two children, told a psychiatrist she had taken the drug while her husband was away and delivered the baby boy by herself at home. She claimed the child was stillborn, but has refused to reveal the location of the body.

Catt pleaded guilty in July to administering a poison with intent to procure a miscarriage.

Evidence presented in court suggested a complex history of pregnancy and childbirth: Catt gave up a child for adoption in 1999, she later had a termination with the agreement of her husband, tried to terminate another pregnancy but missed the legal limit and concealed another pregnancy from her husband before the child’s birth.

Sentencing her to eight years in prison, the judge said Catt had made a “deliberate and calculated decision” to end her pregnancy.

Ch Insp Kerrin Smith, who led the North Yorkshire Police investigation, said “Catt has proved to be cold and calculating and has shown no remorse or given an explanation for what she did.”

Commenting on the case Abortion Rights said:

“This is a sad and unusual case and one that highlights the desperation women can feel when faced by an unwanted pregnancy and when they feel their options are closed.

The upper legal time limit for abortion in this country is 24 weeks in most cases, and while we do not condone anyone operating outside the law, the case underlines how vital it is for women to have access to safe, legal abortion as early as possible in pregnancy.

The reason why we do not see situations like this in the UK is because in the vast majority of cases women do have access to high quality abortion services and good advice on their pregnancy options.

Sarah Catt is clearly a very troubled individual, with a complex medical history. An eight year jail term in such a case is disproportionate.

Women who find themselves in what seem like impossible circumstances must be treated with understanding and compassion, and offered treatment if appropriate, not threatened with prosecution.”